- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07771062
Virtual Reality and Moulage Simulation in Diabetic Foot Wound Care Training (VR)
A Comparison of Virtual Reality and Moulage Simulation in Diabetic Foot Wound Care Training With Routine Practice: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To compare the effectiveness of VR simulation, moulage simulation, and conventional training for diabetic foot wound care among nurses.
The main questions it aims to answer are:
- Do VR simulation, moulage simulation, and conventional role-play training differ in their effects on nurses' knowledge of diabetic foot care?
- Do the three training methods differ in their effects on nurses' psychomotor skills related to diabetic foot wound care?
- Do the three training methods differ in their effects on nurses' attitudes toward diabetic foot care?
- Do nurses' satisfaction levels differ according to the training method they receive?
Researchers will compare nurses assigned to the VR simulation group, the moulage simulation group, and the conventional role-play group to determine whether VR and moulage-based simulation provide greater educational benefits than conventional role-play training.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ramazan Bozkurt, MSc
- Phone Number: +902542956607
- Email: ramazanbozkurt@sakarya.edu.tr
Study Contact Backup
- Name: Nasibe Y. Filiz, PhD
- Phone Number: +902542956619
- Email: nasibef@sakarya.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a graduate with a bachelor's degree in nursing
- Volunteering to participate in the study
Exclusion Criteria:
- Have graduated from a vocational high school specializing in healthcare or have completed a program in the healthcare field.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moulage Simulation
Training on diabetic wound care will be provided using moulage simulation techniques on high-fidelity simulators.
|
Training on diabetic foot wound care
|
|
Experimental: Virtual Reality Simulation
Training on diabetic foot ulcer care will be provided using VR headsets.
|
Training on diabetic foot wound care
|
|
No Intervention: Conventional Training
Following the theoretical training they receive through conventional teaching methods, they will apply their wound care skills using low-fidelity simulators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetic Foot Knowledge Test
Time Frame: 3 months
|
It consists of a total of 20 questions developed by researchers in accordance with the literature on diabetic foot care and designed to assess the level of knowledge regarding diabetic foot care.
|
3 months
|
|
Attitude Scale Towards Diabetic Foot Care
Time Frame: 3 months
|
The scale, which consists of three sections, is a 10-item measure that evaluates nurses' attitudes toward diabetic foot care; it is the third section of a scale designed to assess nurses' knowledge and attitudes regarding diabetic wounds and their care.
On the five-point Likert-type scale (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree), the best attitude is scored as 5 points, and the worst attitude is scored as 1 point.
The lowest possible total score on the scale is 10 and the highest is 50; a higher score indicates that the nurse has a more positive attitude toward diabetic foot care.
The Cronbach's alpha value for the original scale was 0.728, while the Turkish adaptation study found it to be 0.89.
|
3 months
|
|
Diabetic Foot Wound Care Protocol Checklist
Time Frame: 3 months
|
This was developed by researchers in accordance with the literature.
The steps will be finalized after being reviewed by experts.
It is a checklist used to assess participants' skills in diabetic foot ulcer care.
Each item is scored as either 0 or 1. Participants will receive 1 point for the relevant item when they perform the procedure step, and 0 points if they are unable to perform it.
The literature indicates that a participant is considered successful if this score equals 70% of the total score and is classified as having successfully completed the training.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Status
Time Frame: 3 months
|
This was created to allow participants to rate their satisfaction with the training.
Using a visual analog scale (0 = Not at all satisfied, 10 = Very satisfied), they will be able to evaluate the training by assigning a score between 0 and 10.
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ramazan Bozkurt, MSc, Sakarya University
Publications and helpful links
General Publications
- McCluskey P, McCarthy G. Nurses' knowledge and competence in wound management. Wounds. 2012; 8, 37-47.
- Ferreira, AM, Rigotti MA, da Silva Barcelos L, Simão CMF, Ferreira DN, & Gonçalves RQ. Knowledge and practice of nurses about care for patients with wounds. Journal of Research in Fundamental Care. 2014; 6:1178-1190.
- Abate TW, Enyew A, Gebrie F, Bayuh H. Nurses' knowledge and attitude towards diabetes foot care in Bahir Dar, North West Ethiopia. Heliyon. 2020 Nov 23;6(11):e05552. doi: 10.1016/j.heliyon.2020.e05552. eCollection 2020 Nov.
- Kumarasinghe SA, Hettiarachchi P, Wasalathanthri S. Nurses' knowledge on diabetic foot ulcer disease and their attitudes towards patients affected: A cross-sectional institution-based study. J Clin Nurs. 2018 Jan;27(1-2):e203-e212. doi: 10.1111/jocn.13917. Epub 2017 Aug 3.
- Thomas Hess C. Checklist for factors affecting wound healing. Adv Skin Wound Care. 2011 Apr;24(4):192. doi: 10.1097/01.ASW.0000396300.04173.ec. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-61923333-050.99-516489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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